FDA Allows Spirulina-Based Blue Color Additive

Silver Spring, MD—The U.S. Food and Drug Administration (FDA) is amending its color additives regulations to allow spirulina to be safely used as a blue color additive.

FDA’s actions are in response to a petition filed by Mars, Inc. in January of 2012. Mars, Inc. is an American global manufacturer of food products, including popular candies such as M&M’S and Skittles. The company petitioned for spirulina to be allowable as a safe blue color additive in candy and chewing gum.

Spirulina is a concentrated extract of the dried biomass of the cyanobacteria Arthrospira platensis (A. platensis). The naturally occurring cyanobacteria contains high levels of both chlorophyll and phycocyanins, which, when combined, create a distinct blue-green color. The spirulina is grown, harvested, dried and then soaked in water to extract the water-soluble proteins. Once the extract is filtered and stabilized, it can be used as a blue-green color additive. FDA has defined no upper limits for color additive content to be used in candy and chewing gum, as the process is “self-limiting.” However, the color additive does need to be tested negative for microsystin toxin, which could be present where A. platensis is grown.

The use of spirulina in food had previously been considered generally recognized as safe (GRAS). For a color additive to be defined as safe, there must be “convincing evidence…that no harm will result from the intended use of the color additive.” Mars, Inc. provided FDA with published studies that tested the toxicity of spirulina, which “showed no toxic effects at the doses that were tested.”

FDA’s own research concluded that the no-observed-effect-level (NOEL) of phycocyanins for humans is between 108,000 and 184,500 milligrams/person/day (mg/p/d); studies show that exposure to phycocyanin when consumed as a color additive does not exceed 185 mg/p/d. Based upon this evidence, the FDA approved of Mars, Inc.’s petitioned use of spirulina as a blue color additive to be effective as of September 13th of this year.